VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, F
FDA device recall Z-0404-05 · posted 2005-01-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Catheter separation immediately distal to the nose of the suture wing.
- Action taken
- Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 167 kits
- Distribution
- 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
- Date initiated
- 2004-11-22
- Date posted
- 2005-01-20
- Date terminated
- 2005-12-16
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAXCEL PICC WITH PASV VALVE TECHNOLOGY (K021704) | Catheter Innovations, Inc. | 2002-06-06 |